MRI Characterization of Mammographically Detected DCIS

University of Washington

Status: Active, not recruiting

Conditions: Breast Cancer, Stage 0

Treatments: Diagnostic Test: Breast MRI; Other: Laboratory Biomarker Analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03495011

R01CA203883 (U.S. NIH Grant/Contract)

NCI-2021-12034 (Registry Identifier)

9778

RG3017004 (Other Identifier)

Details and patient eligibility

About

This is a single institution, prospective observational clinical trial for women with mammographically identified calcifications that may represent ductal carcinoma in situ (DCIS).

The purpose of this study is to determine whether quantitative, multiparametric breast MRI performed prior to surgical resection can biologically characterize this common pre-invasive malignancy, ductal carcinoma in situ (DCIS), which typically presents in asymptomatic women as suspicious calcifications on mammography.

Full description

The investigators will assess whether MRI signatures can determine which calcifications identified prior to surgical resection actually harbor DCIS, and whether these imaging features correlate with pathologic markers of proliferation (Ki-67) and inflammation (cox-2) within DCIS lesions.

The investigators will also explore whether quantitative MRI features in the peri-tumoral region correlate with prognostic microenvironment markers of inflammation (TNFα) and angiogenesis (VEGF). Finally, investigators will assess whether a multivariate model using these markers can accurately predict risk of recurrence based on a multi-gene assay (Oncotype DX DCIS score).

Enrollment: 122 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• [Cohort A] Women aged 18 or older with suspicious calcifications identified on mammography without an associated mass
• [Cohort B] Women aged 18 or older with recent biopsy-proven DCIS with residual calcifications present on mammogram after biopsy

Exclusion Criteria for Both Cohorts:

• Patients with prior history of breast cancer in the ipsilateral breast
• Patients with a newly diagnosed breast cancer in the contralateral breast
• Contra-indication to contrast-enhanced breast MRI (e.g. renal insufficiency with GFR<60, contrast allergy, incompatible metal)
• Patients who currently are undergoing chemoprevention therapy (e.g. aromatase inhibitors or selective estrogen receptor modulators)
• Women who are pregnant

Trial design

122 participants in 2 patient groups

Cohort A

Description:

Patient with recently identified calcifications on mammography requiring biopsy. Patients will undergo a quantitative, multiparametric breast MRI as part of their clinical care. MRI will not change need for biopsy, but could identify additional suspicious sites. Only patients diagnosed with pure DCIS at biopsy and eventual surgical excision will receive Oncotype DX DCIS score testing.

Treatment:

Other: Laboratory Biomarker Analysis

Diagnostic Test: Breast MRI

Cohort B

Description:

Patient with recent diagnosis of biopsy-proven DCIS would complete a research quantitative, multiparametric breast MRI as part of their clinical care. Only patients diagnosed with pure DCIS at surgical resection will receive Oncotype DX DCIS score testing.

Treatment:

Other: Laboratory Biomarker Analysis

Diagnostic Test: Breast MRI